NDC 55513-068 - IMDELLTRA (AMG757)
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 55513-068
- Package NDCs from labels
- 55513-068-01
- Manufacturer
- Amgen, Inc | Immunex Rhode Island Corporation
- Effective date
- 2026-06-23
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| IMDELLTRA (AMG757) - Amgen, Inc | Immunex Rhode Island Corporation | Amgen, Inc | Immunex Rhode Island Corporation | 2026-06-23 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| IDkit HP ONE | CITRIC ACID ANHYDROUS AND 13C UREA | Meridian Bioscience Israel Ltd | 8baab7a7-5d20-46ad-9c4a-762992ef6b51 | 2026-07-28 | Warnings, Adverse reactions | 2968PHW8QP |
| GLP-4TE HOMO | AACG-A, AACG-B, ADENOSINUM CYCLOPHOSPHORICUM, BERBERINUM, CALCAREA CARBONICA, CINCHONA OFFICINALIS, CHOLINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, CURCUMA LONGA, METHYLCOBALAMIN, DNA, FERRUM METALLICUM, PANAX GINSENG, L-GLUTAMIC ACID, HEPAR SUIS, HYPOTHALAMUS SUIS, INDOLUM, INSULINUM (HUMAN), IODIUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, L-METHIONINE, PANCREAS SUIS, STOMACH (SUIS), ZINCUM METALLICUM, 7-OXO-DEHYDROEPIANDROSTERONE-3B-ACETATE | Deseret Biologicals, Inc. | bb41a08a-e960-4364-a547-4ad356b2c36d | 2026-07-24 | Warnings | 3KX376GY7L |
| Droptics Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80 | Droptics LLC | 29d7614b-f4b7-48e2-97c5-d1bff27731d2 | 2026-07-22 | Warnings | 6OZP39ZG8H |
| SET 4TE HOMO | ADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUM | Deseret Biologicals, Inc. | e7b8d75b-f2bc-4013-91e7-bf5bbec11a90 | 2026-06-25 | Warnings | C151H8M554 |
| IMDELLTRA (AMG757) | TARLATAMAB-DLLE | Amgen, Inc | 1e7b6163-5d83-42ea-82c9-cf7620cdc782 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | BLA761344 55513-103-01 55513-069-01 55513-068-01 55513-059-01 55513-077-01 55513-077 55513-059 2682969 2682961 2682967 2682971 27ebb1b1-13da-4058-9e0b-65c04dd062fe 1e7b6163-5d83-42ea-82c9-cf7620cdc782 |
| Rohto Cool Relief | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30 | 2026-06-19 | Warnings | 6OZP39ZG8H |
| ACD A | CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE | Terumo BCT, Ltd. | 395aec48-198a-4aed-8e38-7accfb3232f9 | 2026-06-15 | Warnings, Adverse reactions | 2968PHW8QP |
| GUNA-CELL | ACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINC | Guna spa | 90db80ed-c037-4e8f-a7f6-304a65f9fe22 | 2026-06-11 | Warnings | 2968PHW8QP |
| GUNA-FLAM | ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - | Guna spa | 7bda7eb0-8fd5-42d9-b336-39920bfc964d | 2026-06-10 | Warnings | 2968PHW8QP |
| Rohto Max Strength | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | e4b49550-1ca3-4bd7-854d-409b53fa5e26 | 2026-06-03 | Warnings | 6OZP39ZG8H |
| ACD A | CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE | Terumo BCT, Ltd | 8e255bc7-a120-460a-a32d-43931f8115de | 2026-05-21 | Warnings, Adverse reactions | 2968PHW8QP |
| Plenamine | LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, AND TYROSINE | B. Braun Medical Inc. | a3244d1a-45b0-4e4c-bd96-f0632d761a1f | 2026-05-08 | Warnings, Adverse reactions | 3KX376GY7L |
| Connection | ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 4a8be3aa-9bd9-4bb1-af98-a940c13b2bd0 | 2026-04-10 | Warnings | C151H8M554 |
| Connection | ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 214eb19a-e7a2-421c-9f34-724ce430185c | 2026-04-10 | Warnings | C151H8M554 |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID | Chartwell Governmental & Specialty RX, LLC | 58c24504-47de-487a-ab8d-18add155ea95 | 2026-04-07 | Adverse reactions | 2968PHW8QP |
| Drop20 | FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE) | Pick Enterprises Corp | baa96813-dc95-472e-a834-880a0cd484a7 | 2026-03-13 | Warnings | C151H8M554 |
| Appetrol 20 | FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE) | Carbalor LLC | d66234a3-2477-42be-8f7b-283e3a5f87ed | 2026-03-12 | Warnings | C151H8M554 |
| Refresh Optive Mega-3 PF | CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80 | Allergan, Inc. | 326cb5d6-c784-404f-9a13-6d69262dda6e | 2026-03-01 | Warnings | 6OZP39ZG8H |
| Tricitrates | TRICITRATES | Chartwell Governmental & Specialty RX, LLC. | c4ff0407-3930-4c48-afd4-d2cb3e1b18f4 | 2026-02-25 | Warnings, Adverse reactions | 2968PHW8QP |
| Potassium Citrate and Citric Acid | POTASSIUM CITRATE AND CITRIC ACID | Chartwell Governmental & Specialty RX, LLC. | fd57a176-7faf-4053-b348-6ba5f192f05a | 2026-02-25 | Warnings, Adverse reactions | 2968PHW8QP |